Allomap blood tests cleared by FDA

September 25, 2008 7:15:04 PM PDT
We have an update a new technology that's changing the lives of transplant patients. We first told you about clinical trials of the Allomap blood test late last year. The results have been so successful; it's now received FDA clearance.

For most of us, giving blood is nothing to get excited about. For Richard Locke, it's a joy.

And if he seems almost giddy, it helps to understand what a six month check up used to be like, after Richard first received his heart transplant at California Pacific Medical Center in San Francisco.

To guard against the danger of rejection by his immune system, doctors had to take tissue samples, directly from his heart for a biopsy.

"You go in, take a picture, they punch a hole in your neck and run a catheter up here into your heart, and there is a camera too and they're televising this, using all kinds of equipment," said Locke.

But now, within hours, that small blood sample Richard had taken in San Francisco is on its way to a sophisticated lab in Brisbane. There, technicians will test the gene expression in Richard's white blood cells, for the earliest signs of rejection.

"We're looking at RNA, the messenger RNA in layman's terms, it's the messengers of the immune system preparing to mount an attack," said Pierre Cassigneul from XDX Diagnostics.

Cassigneul founded XDX Diagnostics, which developed the specialized blood test known as Allomap. To prove the technology, he says the company compared Allomap results against biopsy results performed by four separate pathologists.

"Yes, we were able to prove we were as good as those four combined pathologists reading the slide," said Cassigneul.

During the clinical trials, Richard along with hundreds of other test patients received both biopsies and the Allomap tests for safety.

Now, with clearance his check-ups involve just the 10-minute blood test. As for his transplanted heart? No sign of rejection.

"I feel great, I feel great, life is good," said Locke.

The Allomap results are encouraging enough that the company is now in clinical trials on a version to monitor lung transplant patients as well.


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